Device for preventing involuntary micturition

ABSTRACT

A device for preventing involuntary micturition, preferably in human females, comprises an oblong, comparatively thin shaft (1). This shaft (1) carries at least one knob (2, 3, 4) forming a thickening on the shaft (1) and being arranged at a distance from the proximal end of the shaft (1). The proximal end of the shaft (1) is provided with a comparatively thin, transverse flap (5).

TECHNICAL FIELD

The present invention relates to a device for preventing involuntarymicturition, preferably in human females.

BACKGROUND ART

Numerous devices for preventing involuntary micturition in human femalesare known. Such devices include for instance a device inserted in theurethra by means of a special instrument, said device expanding in theurethra when the instrument is removed. Such devices are usuallydifficult to manipulate and irritate a patient during use.

DISCLOSURE OF THE INVENTION

The object of the present invention is to provide a device easy toinsert and causing no irritation to a patient carrying the device.

The object of the invention is accomplished by a device comprising anoblong, substantially form-stable, flexible body with varyingcross-sectional area depending on the distance from an end of the bodyand providing at least one knob forming a thickening arranged at adistance from a first end of the body, and that the first end of theoblong body is provided with a comparatively thin, transverse flap,extending substantially perpendicular to the axis of the body.

As a result the inventive device is easily inserted in the urethra andhas shown itself to be unproblematic during use. Moreover the device iseasily removable, since it can be pressed out by the user duringvoluntary micturition. Optionally it can also be withdrawn by holding onto the flap. The flap acts also as a safeguard against the device beingtoo deeply inserted in the urethra. Further the inventive device is ofspecial advantage with respect to prevention of involuntary micturitiondue to its tendency to position itself in such a way that the knobs arelocated within the strongest sections of the urethral muscles, thusincreasing the sphincteral pressure of the urethra.

In an especially preferred embodiment the oblong body is a shaftcomprising three mutually spaced knobs.

In accordance with the invention the knob or knobs can be of ellipsoidshape thus achieving an especially gentle and well-functioningco-operation with the surrounding urethral tissue and muscles.

Further in accordance with the invention, the thin, transverse flap canhave the form of an annular disc. Thus the inventive device is easy tomanipulate during the insertion and the optional withdrawal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an especially suitable embodiment of aninventive device, and

FIG. 2 is a graphic representation of the pressure in the urethra of aperson with a normally functioning urethra, and of a patient sufferingfrom urinary incontinence.

BEST MODE FOR CARRYING OUT THE INVENTION

The device of FIG. 1 comprises an oblong body in form of a comparativelythin shaft 1 with three mutually spaced ellipsoid knobs 2, 3 and 4, theknob 4 being at the distal end of the shaft, said end being placedfurthest inside the urethra during use. The proximal end of the shaft 1is provided with a thin disc 5.

In a preferred embodiment the device is of a length of approx. 5 cm, andthe shaft 1 is of annular cross-section with a diameter of approx. 2 mm.The knobs 2, 3 and 4 have a mutual distance of approx. 4 mm and theirlargest diameter measured perpendicular to the shaft is approx. 7 mm.The length of the knobs 2, 3 and 4 is approx. 8 mm, measured in thelongitudinal direction of the shaft. The annular disc 5 is of a diameterof approx. 14 mm and of a thickness of less than 0.5 mm. The entiredevice is suitably integrally made of a comparatively soft plasticmaterial having such a rigidity that it is easily inserted in theurethra. The shaft is optionally hollow to receive an insertion means inform of a long, thin pin. The plastic material is preferablytissue-compatible and desinfecting.

The urethra of an adult human female is usually of a length of 3-5 cmand surrounded by muscles over its entire length from the bladder to theexternal urethral ostium. The strongest muscles of this muscle group aresituated adjacent the bladder as well as in the middle of the urethra.These muscles usually seal off the urethra. A graphic representation ofthe pressure maintaining a sealed urethra in a human female usuallyfollows a curve depicted at I in FIG. 2. The abscissa indicates thelength of the urethra measured from the bladder to the external urethralostium (M), and the ordinate indicates the pressure measured in Pa.Usually the pressure in the urethra is approx. 600-700 Pa. Theintravesical pressure of a person standing upright is normally between300 and 400 Pa, as indicated by means of curve II in FIG. 2. Thus thenormal safety margin is approx. 400 Pa over the entire length of theurethra. Curve III of FIG. 2 shows a pressure distribution for theurethra of a patient suffering from incontinence. As is apparent, only ashort part of the urethra, i.e. approx. 5 mm, is subjected to asphincteral pressure higher than the intravesical pressure.

The device of FIG. 1 was tested with the patient on which the pressuredistribution of curve III, FIG. 2, was measured. Prior to insertion ofthe device the ability of the urethra to retain liquids was tested. Thebladder was filled with 300 ml water (75% filled), whereupon the personwas asked to take the elevator up to the next floor and return via thestaircase. This trip was repeated twice. During the experiment theperson lost the 300 ml water and additionally approx. 50-100 ml liquidproduced during the experiment.

The experiment was then repeated with the device of FIG. 1 inserted inthe urethra. During this experiment the person lost only approx. 15 ml.

An examination of the position of the device in the urethra revealedthat the knob 2 closest to the disc 5 was about in the middle of theurethra, i.e. within the area where the sphincteral pressure is highest,while the two following knobs were positioned in the vesical ostium andinside the bladder, respectively. It cannot be excluded that the twolatter knobs had some effect with respect to retaining liquid, but thepresence of three knobs 2, 3 and 4 allows the device to obtain a betterposition with respect to the muscles of the urinary tract compared to adevice with only one knob. By measuring the pressure in the urethra of apatient suffering from incontinence it is apparent where the muscles arestrongest, thus permitting the selection of the device bestcorresponding to the needs of the patient in question. In such a casethe distances between the knobs and the annular disc 5 may differ fromthe ones above.

The above experiment was repeated with other patients, i.a. also withmen, and had the same promising results.

A special characteristic of the inventive device is that it turned outto act as a stimulant to the urethral muscles. Experiments have shownthat these muscles displayed a temporary increase in strength after useof the inventive device.

The invention is described with respect to a preferred embodiment. Manyalterations can, however, be made without thereby deviating from thescope of the invention. The knobs can be of a shape other thanellipsoid. The annular disc can be replaced by a small strip projectingto one side with respect to the shaft. The device can, if so desired, beprovided with a cavity (6) as to increase its flexibility. This cavitycan for instance open outwardly at the end where the annular disc islocated. In such a case the inventive device can be inserted by means ofa stiff, oblong means 7 inserted in the cavity (6) and removed after theinventive device has been positioned in the urethra. The number of knobscan, if desired, also differ from the one shown. Instead of a thin shaftwith knobs the oblong body can be of larger diameter and provided with anumber of recesses.

I claim:
 1. A device for preventing involuntary micturition, preferablyin human females, comprising a substantially solid oblong, substantiallyform-stable flexible body with varying cross-sectional area depending onthe distance from an end of the body and providing at least one knobforming a thickening arranged at a distance from a first end of thebody, said knob sized to pass into the urethra and to retain the devicein the urethra, and that the first end of the oblong body is providedwith a comparatively thin, transverse flap, extending perpendicular tothe axis of the body.
 2. A device as claimed in claim 1, characterizedin that the oblong body is a shaft (1) having three mutually spacedknobs (2, 3, 4).
 3. A device as claimed in claim 1, characterized inthat the knob or knobs (2, 3, 4) are of a substantially ellipsoid shape.4. A device as claimed in claim 1, characterized in that the thin,transverse flap (5) has the shape of an annular disc.
 5. A device asclaimed in claim 1, characterized in that it is made in form of oneintegral part of a plastic material.
 6. A device as claimed in claim 1,characterized in that the body (1) is provided with a cavity (6) with anopening at the flap (5).
 7. A device for preventing involuntarymicturition, comprising a thin shaft having a first end, a second endand a closed-ended cavity, said shaft having three mutually spaced,ellipsoidal knobs arranged near the second end, said knobs being sizedto pass into the urethra and to retain the device in the urethra, saidcavity having an opening at said first end to receive an insertionmeans, said first end being attached to a thin, transverse flap in theshape of an annular disc, and said device being formed from a singlepiece of soft plastic.
 8. A micturition controlling devicecomprising:means for preventing involuntary micturition, said meanscomprising a closed shaft and having a first end and a second end; meansfor positioning the preventing means in the urethra, said positioningmeans being located on the preventing means near the second end, saidpositioning means shaped and situated to cooperate with urethralmuscles, said positioning means being sized to pass into the urethra andto retain the device in the urethra; and means for facilitatingwithdrawing the preventing means, said facilitating means being attachedto the first end of the preventing means, said facilitating meansfurther preventing the device being too deeply inserted into theurethra.
 9. A device as in claim 8, wherein said preventing meanscomprises a shaft of variable diameter.
 10. A device as in claim 9,wherein said shaft comprises at least one knob which is located near thesecond end of the shaft and which facilitates positioning of the devicewithin the urethra.
 11. A device as in claim 10, wherein said knob is ofa substantially ellipsoidal shape.
 12. A device as in claim 9, whereinsaid shaft comprises three mutually spaced knobs which are located nearthe second end of the shaft and which facilitate positioning of thedevice within the urethra.
 13. A device as in claim 8, wherein saidfacilitating means comprises a transverse flap.
 14. A device as in claim13, wherein said transverse flap has the shape of a thin, annular disk.15. A device as in claim 8, further comprising means for insertion, saidinsertion means comprising a cavity in said shaft having an opening atthe first end of the shaft and a means for filling the cavity.
 16. Adevice as in claim 15, wherein said filling means is a long, thin pin.17. A device as in claim 8, wherein said device is made of one integralpiece of soft plastic.
 18. A device for preventing involuntarymicturition comprising:a substantially solid shaft of variable diameterfor preventing micturition, said shaft having a first end and a secondend; at least one knob for positioning the shaft in the urethra, saidknob being located on the shaft near its second end, said knob beingshaped and situated to cooperate with urethral muscles, and said knobbeing sized to pass into the urethra and to retain the device in theurethra; a transverse flap for facilitating withdrawing the shaft, saidflap being attached to the first end of the shaft, said flap furtherpreventing the device being too deeply inserted into the urethra.
 19. Adevice as in claim 18, wherein at least one knob comprises threemutually spaced knobs.
 20. A device as in claim 18, wherein said knob isof a substantially ellipsoidal shape.
 21. A device as in claim 18,wherein said transverse flap has the shape of a thin, annular disk. 22.A device as in claim 18, wherein the shaft, knob, and transverse flapare made of one integral piece of soft plastic.
 23. A device as in claim18, further comprising a pin for insertion, said pin being inserted intoa cavity with an opening at the first end of the shaft.
 24. A method forcontrolling involuntary micturition, comprising the followingsteps:providing an elongated shaft, said shaft having a first end and asecond end, a transverse flap being attached to the first end, and atleast one knob being located on the shaft near the second end, said knobbeing sized to pass into the urethra and to retain the shaft in theurethra; grasping the shaft by the first end; inserting the second endof the shaft into the urethra; leaving the shaft in the urethra untilmicturition is to be performed; and then removing the device from theurethra to empty the bladder.
 25. The method of claim 24, wherein theprovided shaft further comprises a longitudinal cavity opening at thefirst end of the shaft, said method further comprising the followingsteps:after grasping the shaft, inserting a long, thin pin into thelongitudinal cavity; and after inserting the shaft, withdrawing thelong, thin pin from the longitudinal cavity.
 26. The method of claim 24,wherein the step of grasping the shaft comprises grasping the transverseflap.
 27. The method of claim 24, wherein the step of insertingcomprises advancing the shaft into the urethra until only the transverseflap remains outside the urethra.